FDA.reportPublic FDA data

CVS Regular Strength Itch Stopping Cream Drug Facts

Manufacturer
CVS | Weeks & Leo Co., Inc.
Effective date
2023-12-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:03:54

Label at a glance#

ProductCVS Regular Strength Itch Stopping
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure8 sections

Indications and uses

temporarliy relieves pain and itching due to: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac dries the oozing and weeping due to poison: ivy oak sumac

Dosage and administration

do not use more often than directed adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily children under 2 years: ask a doctor

Storage and handling

store at 20º C to 25º C (68º F to 77º F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

OTC - PURPOSE SECTION

Diphenhydramine hydrochloride...............Topical anagesic

Zinc acetate..............................................Skin protectant

Uses

INDICATIONS & USAGE SECTION

temporarliy relieves pain and itching due to:

  • insect bites
  • minor burns
  • sunburn
  • minor skin irritations
  • minor cuts
  • scrapes
  • rashes due to poison ivy, poison oak, and poison sumac

dries the oozing and weeping due to poison:

  • ivy
  • oak
  • sumac

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • on chicken pox
  • on measles

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more often than directed
  • adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • store at 20º C to 25º C (68º F to 77º F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, diazolidinyl urea, glyceryl stearate, methylparaben, PEG-40 stearate, PEG-100 stearate, propylene glycol, propylparaben, purified water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display PanelRelieves pain from insects bites & skin irritation

Topical Analgesic

Skin Protectant

ITCH Itch relief CREAM

compare to the active ingredients in Benadryl ® Orignial strength itch stopping cream

Relieves Pain & Itch fast

Itch stopping Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1292313diphenhydrAMINE HCl 1 % / zinc acetate 0.1 % Topical CreamPSN6
1292313diphenhydramine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD6
1292313diphenhydramine hydrochloride 1 % / zinc acetate 0.1 % Topical CreamSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-621-01CVS Regular Strength Itch Stopping28 g in 1 TUBECREAM286
69842-621-01CVS Regular Strength Itch Stopping1 in 1 CARTONCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-621CVS REGULAR STRENGTH ITCH STOPPING (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CVS]6Current NDC, Legacy NDC, 2 package rows20231212_87473ace-d834-e43f-e053-2a95a90a819c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-62169842-621-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PEG-40 STEARATEECU18C66Q7IACT
PEG-100 STEARATEYD01N1999RIACT
CETYL ALCOHOL936JST6JCNIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ZINC ACETATEFM5526K07AACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Regular Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECVS87473ace-d834-e43f-e053-2a95a90a819c2023-12-11WarningsExact identifier
ndc (package): 69842-621-01
ndc (product): 69842-621
ndc11 (package): 69842062101
spl id: 0c41d2ea-62ed-3ceb-e063-6294a90ab561
spl set id: 87473ace-d834-e43f-e053-2a95a90a819c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.